Friday, May 29, 2009

DDMAC's (FDA) recently-released "Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion" (pdf file here) focuses almost exclusively on print and broadcast promotional ads. It mentions the Internet -- where patients most often go first to find information on health (see, for example, "The Empowered Patient: What It Means for Pharma Marketers"; PMN Reprint #84-02) -- only once by way of example, as in:

"Example 13: If a Web site for a product approved to treat high blood pressure presents information about a product’s benefits in postmenopausal women, any risks specific to postmenopausal women are particularly material."

To illustrate how non-specific this is with regard to the Internet, all you have to do is substitute "Print ad" for "Web site." Perhaps this is FDA's way of saying that the same rules apply to the Internet as to print ads. I agree, but only so far as a Web page or display ad on the Internet is just another static piece of text/graphic. We used to call such Web sites "brochureware."

Although the Internet has evolved to be much more interactive and user-generated, the FDA has evolved much less. We'll have to wait for Obama-era appointees to work their way down the hierarchy at FDA before we see the FDA evolve more quickly. For now, this draft guidance, which was in the works for at least a year, will have to do.

The Internet may have evolved, but most of the drug advertising on it is pretty much the same as it was 5-10 years ago: static display search engine ads. Included in this category are the 70-character Google Adwords that were the subject of FDA's recent 14 notices of violation. These notices cited the lack of adequate fair balance in search engine ads that mentioned the drug name and benefits; ie, they lacked side effect information.

I have always contended that these ads violated FDA regulations (see "Girl from Google"), but pharma marketers thought I was crazy (see "The 'One-Click Rule': Rant or No Rant?") because, as every sane person knew, there was a "one-click rule" that allowed such ads as long as the risk information was just one click away (ie, on the landing page).

That's water over the dam, so let's move on.

It is quite easy to extrapolate from the current FDA draft guidance on presenting risk information in print ads to static Internet ads like Adwords. This may be like reading tea leaves, but since I have a good batting average when it comes to understanding the application of FDA regulations to Internet advertising, you just might want to listen to my POV. It could save you from a NOV letter down the road. And as Arnie Friede, counsel to the law firm McDermott Will & Emery LLP and former Senior Counsel at Pfizer, says, "every warning letter or notice of violation has another life--in a court of law" (see "Ramifications of FDA Regulatory Actions"; PMN Reprint #85-02).

I find the most relevant tea leaves on page 15 of DDMAC's draft guidance. It's under the section "Print Promotion." Just think of an Adword or static banner or box ad as equivalent to a print piece. Yes, you can click on it and get more information, but the FDA probably considers the ad itself as the "main piece" and says:

"For a piece to be accurate and non-misleading, risk information should be included in the main part of a piece. If the omission of risk information in any part of a piece makes that part of the piece false or misleading, the problem cannot be corrected simply by including the risk information in a separate part of the piece [my emphasis]. To be comparably prominent to benefit information, risk information should generally appear in the same parts of the piece as the benefits."

"As a general matter, risk and benefit information should be comparably noticeable or conspicuous in promotional pieces, and audiences should be able to read both risk and benefit information with similar ease [my emphasis]."

and

"Complete separation of benefit and risk information (e.g., presenting several pages of benefits before any risks) is one example of a lack of appropriate prominence."

and

"Example 17: Risk information is placed in a thin column along the side of an ad in a different font and color scheme, so that the visuals and benefit information form a complete whole, separate from the risk information. This is not likely to be considered an adequate presentation of risk 582 information." [Although this is about a print ad, it is easy to read the tea leaves here and extend the thinking to Internet display ads.]

I think no matter how you define a "reasonable man," having to click a link in an Adword to get fair balance is not as easy as reading the benefits right there in front of you. Be honest, how often do you just read the first part of a news story in a newspaper without bothering to flip through to the page where it is continued? Even if you are reading the online version? I bet half of you have not even read this far into my post!

And, I'm also willing to bet that more than 95% of people (ie, "reasonable consumers") who view Adwords do NOT click on them (if you have some secret sauce for increasing the clickthrough rates on Adwords, please let me know). Nevertheless, the ad has some value -- building brand awareness as marketers say.

With regard to FDA's view of a "reasonable man," the following excerpt from the draft guidance document is relevant:

"Consumers have preconceived ideas about the amount of scrutiny these ads undergo. Many believe FDA exercises tight regulatory control over the content of these ads and to some extent, believe that all ads have been pre-reviewed prior to airing. As a result, consumers are likely to expect that the most relevant risks have been included in the ad."

Imagine what a "reasonable consumer" would think if they saw a drug ad with NO risk information included in the main piece?

Be reasonable and read the DDMAC draft guidance at least through page 16.

5 comments:

The one thing I can't understand about all of this is why the FDA won't address the internet.

Is it because of lack of understanding or lack of resources or maybe something more sinister that someone may be holding them back because they don't want this can of worms opened up.

The pharma industry has so much money and so much distrust from the public but yet they can't converse (notice that this is different than shouting at us on TV) with the public that really needs to speak with them. They need the transparency that the internet offers.

The funny thing is a lot of internet marketers are probably upset over this new "draft" info and how they can't effectively use Google Adwords or banner ads.

Big deal.

If you want something that really works, you need to be using social media and speaking directly to your customers. Maybe you can use some of the wasted funds that you were dumping into Adwords and start hiring smart, sympathetic people that can represent your brand in an authentic way online and help people (not just paying them to praise you!!!!)

It's a whole new world out here in marketing and consumers are more in control than ever. And that is the way it should be.

Pharma and FDA need a task force to address this right now and if the FDA doesn't have the manpower, pharma should form a coalition on their own and come up with fair regulations for online engagement. This is too important to wait any longer.

I like this. Good analysis! I think you are right on with respect to the reality of FDA's thinking and a "reasonable" and practical intepretation of the guidance. I believe, indeed, you're on target with how FDA (at least DDMAC) is thinking about this.

I think Arnie's thinking and approach is also "right on" however. In spite of your realistic perspective on how FDA will interpret the "reasonable man" standard, FDA (contrary to certain public opinion and perhaps to opinions of certain FDA officials themselves) FDA is not omnipotent and is not sole and ultimate arbiter of truth, reasonableness, or of correct interpretation of the law. There are many degrees of reasonableness, and many variations of form on what an advertisement or labeling can be, particularly on the internet, and Arnie is "dead on" in his critique. While FDA may use social science and market research to support its policies or general perspectives on enforcement issues, in the end a single enforcement case presents unique circumstances. In any case, in an individual enforcement situation the "reasonable man" (or woman) is a sample of one or perhaps a few people in DDMAC (who often themselves disagree). FDA's enforcment actions are not (and will not be) substantiated by research into the reasonable men and women who are actually the target audience of the ad (or any research sample at all).

Are you a "reasonable man"? Do you disagree with people now and then? Do you disagree with DDMAC now and then?

Arnie's, and others', pursuit of this issue (among others) is very important in spite of the current realities that you articulate. I think, by the way, that there are lots of other issues with this guidance that also need to be pursued in dialogue with the FDA. For instance, this guidance leaves little room for any innovation to actually improve risk communication in advertising or promotion. Ironically, it simply solidifies the current communication model with more restrictions, a model that so many stakeholders are dissatisfied with. At best, we can expect improvement in compliance, but likely not improvement in risk communication (these are, in many ways, independent).

By the way, this is what you get when you ask for guidance from FDA, and for perspective, this guidance (even though sorely needed perhaps more than any other topic, including internet and social media) has been in the works for years and years and years and years. Hopefully, the new administration will fix the timeliness of guidance and rulemaking (which it has said it intends to work on).

Somebody should send the FDA a telegram and explain to them that times have changed. DDMAC's lack of guidance on the use of social media, and their knee-jerk reaction in sending warning letters to companies regarding Internet drug ads, smacks of a bureaucracy that is woefully overwhelmed. Perhaps a shift back toward a more collaborative realtionship with industry might serve them better. In the past, FDA worked more closely with industry, and more seemed to get done. Funny that.

Before people spend more time chasing the "reasonable man" ball, let's get clear about this. FDA is not talking about just any "reasonable man"; they specifically reference the "reasonable consumer" as described in the 1983 FTC Policy Statement on Deception. Please note:

1) This is not a casual label that anybody can staple their own definition on.

2) It does not require the MOST reasonable projection of what the "reasonable consumer" may say or do. Indeed, an interpretation that is held by merely a significant minority may still be considered "reasonable."

3) When possible, the basis for that "reasonable consumer" should indeed be evidence based. And, the FDA Draft Guidance does cite its evidence basis. Apart from the usual assortment of usability studies, the base for consumer and HCP projections of "reasonable" is their own set of surveys, summarized in Aikin, Swasy & Braman: "Patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs."

You want to argue with DDMAC? Fine, they need arguing with. But first, do your homework, eh?

About the Author

Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own.